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Autopsies Find Possible Cause Unclean Surgical Instruments

Relatives of a woman, who died after she underwent a sterilization surgery at a government mass sterilization camp take part in her funeral rites at her home in Bilaspur district, in the state of Chhattisgarh.
Reuters

BILASPUR, India—Initial autopsies of 12 women who died after operations at an Indian government sterilization camp last week indicate two main possible causes, local officials and doctors said Friday: medical mistakes and tainted drugs.

Postmortem examinations of seven of the women conducted at the Chhattisgarh Institute of Medical Sciences, a state-funded public hospital that treated women who became ill after the procedure, pointed to an infection spread by unclean surgical instruments, a forensics specialist said.

Praveen Tayade,
head of forensic medicine at the institute, said Friday that septic shock brought on by a severe infection was the “likely cause of death.” Final autopsy reports haven’t been completed, he said.

Amar Agrawal, health minister for the state of Chhattisgarh, where the sterilization camp was held on Nov. 8, said proper “protocol was not followed.” He said the exact cause of death remains unclear and that authorities were also testing drugs used to treat the women.

India’s state governments periodically schedule opportunities for mass sterilization at established hospitals and medical centers that are referred to as “camps.” The national government, seeking to curb population growth in the country of 1.2 billion, offers cash incentives to women, physicians and health workers participating in the surgeries. Around 4.5 million women were sterilized in the year ended March 31, 2013.

A woman who underwent sterilization surgery at a government sterilization camp, in a hospital in Bilaspur, Indian, Thursday.
Anindito Mukherjee/Reuters

Health activists criticize the government’s focus on female surgical sterilization as a cornerstone of the nation’s family-planning program. In a recent government survey, 34% of households nationwide said female sterilization was their current method of family planning.

Earlier this week, police arrested a surgeon,
R.K. Gupta,
on suspicion of committing culpable homicide in connection with the Nov. 8 sterilization camp. Dr. Gupta operated on 83 women over several hours as part of the population-control campaign. Dr. Gupta has said he is being made a scapegoat. He blamed faulty drugs for the deaths.

Mr. Gupta, who hasn’t been charged, was still being detained Friday night. He has retained a lawyer.

L.C. Madharia, the head of a local medical association, defended Dr. Gupta, saying he had adhered to “all accepted precautions.”

The state’s principal secretary of health,
Alok Shukla,
said officials were looking into whether the common antibiotic ciprofloxacin, bought by the state from a local pharmaceutical company and used to treat the women, had been adulterated and played a role in the deaths.

Mr. Shukla said that other patients who had taken pills from the same batch as the women who died had also become ill, including women who underwent surgery at another sterilization camp on Monday as well as patients being treated for other conditions. One woman who was surgically sterilized Monday also died.

A nurse tends to a woman, who underwent a surgery at a government mass sterilization camp. She is at Chhattisgarh Institute of Medical Sciences hospital in Bilaspur, India, Thursday.
Anindito Mukherjee/Reuters

Police in Raipur, the state capital, detained a father and son,
Ramesh Mahawar
and
Sumit Mahawar,
who run Mahawar Pharma Pvt. Ltd., which supplied the ciprofloxacin. The men, who were in custody, couldn’t be reached for comment. The company said in a statement to the Indian Express that the drug is widely sold and the company has “never received any complaint.”

Samples of the ciprofloxacin and other medicines given to the sterilization patients have been sent for laboratory testing. Health officials said results could be available Friday or Saturday.

Ravi Prakash Gupta,
a state drug inspector, said that “there were many irregularities” at the Mahawar plant. He said his team of drug-control officers visited the plant Tuesday night and Wednesday. The police raided and sealed the plant Thursday night, he said.

Women who underwent surgery at a government mass sterilisation camp lie in hospital beds for treatment in Bilaspur, India, Thursday.
Anindito Mukherjee/Reuters

“They have manufacturing facilities but no manufacturing was going on,” Mr. Gupta said. “We suspect they were only getting drugs from elsewhere.”

The Indian pharmaceutical industry has come under scrutiny in recent years for a string of quality- and safety-related problems. U.S. regulators have barred imports of drugs from a number of Indian factories because of poor manufacturing practices.

Roughly a quarter of medicines examined between 2011 and 2013 by state inspectors in Chhattisgarh were “not of standard quality,” according to documents from the Central Drugs Standard Control Organization reviewed by The Wall Street Journal. The number of drugs tested was small, however.

Dr. Tayade, the forensic-medicine specialist, said the autopsies on the dead sterilization patients found evidence of inflammation and other signs of septicemia, which he said was “because of infection due to the use of unsterile instruments in the surgeries.”

A contaminated drug alone would be unlikely to cause death in this fashion, he said. But if the antibiotic was of poor quality or not potent enough, it could have contributed to the patients’ inability to fight off an infection introduced by the surgery.

A visit by Journal reporters to the hospital where the Nov. 8 surgeries took place found its floors covered with animal feces. The operating rooms were padlocked and couldn’t be seen. A caretaker at the hospital said it hadn’t been in regular use since April.